Embodiments herein generally relate to implantable cardiac monitoring devices, and more particularly to implantable cardiac monitoring devices with headers having embedded components.
An implantable cardiac monitoring (ICM) device is a medical device that is implanted in a patient to, among other things, monitor electrical activity of a heart. An ICM device may record cardiac activity of a patient over time and report such cardiac activity to an external device. The ICM device may optionally perform various levels of sophisticated analysis of the cardiac activity and based thereon perform additional recording operations. The ICM device may also be configured to deliver appropriate electrical and/or drug therapy, and as such is also referred to as an implantable medical device (IMD). Examples of IMDs include pacemakers, cardioverters, cardiac rhythm management devices, defibrillators, and the like. The electrical therapy produced by an IMD may include, for example, pacing pulses, cardioverting pulses, and/or defibrillator pulses. The device is used to both provide treatment for the patient and to inform the patient and medical personnel of the physiologic condition of the patient and the status of the treatment.
In general, an ICM include a battery, memory and electronic circuitry that are hermetically sealed within a metal housing (generally referred to as the “can”). The metal housing typically is formed of titanium and includes a shell (e.g., opposed concave half shells that are welded together, a “deep drawn shell, etc.) to form a device housing with an interconnect cavity, in which the battery, memory, pulse generator and/or processor module reside. The half shells have an oval contour with a header receptacle area configured to receive a header assembly. A feed-through assembly is located at the header receptacle area and is sealed to the device housing to form an interface for conductors to enter/exit the interconnect cavity.
However, ICM devices and methods of manufacture have experienced certain limitations. Certain types of ICM devices include one or more sensing electrodes and an antenna that are located within the ICM device. For example, the sensing electrode/electrodes and antenna may be located in the header of the ICM device. Heretofore, the sensing electrodes and antenna were joined to the device in a manner that required extensive secondary operations for buffering, sanding and cleaning the header and the device during assembly.
A need remains for improved ICM devices and methods of manufacture.